Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure

Not Applicable

Active, not recruiting

• Conditions: Linear Cutaneous Wound
• Interventions: Other: Standard of Care; Device: Embrace Scar Therapy Device

• Registration Number: NCT03294863
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis.

Detailed Description

The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis. We will use a split wound model, half of the wound is treated with the embrace device and the other half is not treated. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width and adverse events will also be recorded.

Following the surgical repair of cutaneous wounds, scar formation is inevitable and results in varying degrees of aesthetic and/or functional impairment. Numerous treatment modalities have been employed to treat scars. Carbon dioxide and pulse dye lasers, as well as dermabrasion can reduce erythema and irregular topology of the scar surface1,2. Silicone-based products have also been used to treat post-surgical scars, including gels, sheets, and tape3-5. Intralesional steroids are often injected into to induce flattening of a scar6. More recent research has highlighted the impact of mechanical forces and tension on scar formation. In one report, incisions in both pigs and humans were treated with a tension-shielding device and showed a reduction in scarring7. More recently two clinical trials have been published in the plastic surgery literature showing that the use of the embrace device, a silicone-based dressing designed to minimize wound tension, is effective in improving the aesthetic outcome following scar revision surgery8,9. While these initial studies of the embrace device have promising findings, there are significant drawbacks to both studies including small study population, inclusion of patients seeking scar revision (a select group likely predisposed to poor scar cosmesis and not representative of first-time surgical patients), investigator conflict of interest, and the use of a digital software-based scar assessment tool using patients photos that were not standardized with respect to lighting or distance. Therefore, larger studies in first-time surgical patients with standardized photos for scar assessment are required to validate this potentially promising device for improved scar cosmesis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure along a flat surface suitable to application of the embrace with predicted primary closure.
• Able to apply dressings themselves.
• Willing to return for follow up visits.

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Exclusion Criteria

• Mentally handicapped
• Unable to understand written and oral English
• Incarceration
• Under 18 years of age
• Pregnant Women
• Wounds with predicted closure length less than 3 cm
• Patients with known adverse reactions to adhesives
• Patients with history of collagen vascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Another 1/2 of cutaneous wound will be treated per standard of care
Embrace Scar Therapy Device	Embrace Scar Therapy Device	16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive will be applied to 1/2 of the cutaneous wound

Primary Outcome Measures

Name	Time	Method
Physician observer scar assessment score (POSAS)	3 months	Comparison of scar cosmesis over area of wound that was treated with the device as compared to area that was not treated with the device.
Width of the scar	3 months	The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar

Trial Locations

Locations (1)

University of California, Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States